Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-01-02 @ 8:09 AM
Study NCT ID:
NCT05121558
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2021-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Yoga on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'C564945', 'term': 'Neuropathy, Painful'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': "The PI and investigators, will be blinded to the patient's group assignment."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3-arm parallel randomized controlled trial (RCT) comparing yoga to a non-physical education control (EC) and usual care.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 268}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2021-11-04', 'studyFirstSubmitQcDate': '2021-11-04', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measuring Chemotherapy-Induced Peripheral Neuropathy pain severity after Yoga', 'timeFrame': 'up to 24 weeks', 'description': 'as measured by the Brief Pain Inventory-Short Form (BPI-SF) compared to EC and UC arms at week 8 response choices of 0 ("no pain") to 10 ("pain as bad as you can imagine").'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Yoga', 'Chemotherapy-induced Peripheral Neuropathy', 'Neuropathic Pain', 'Pain Management', 'Dana-Farber Cancer Institute', 'Memorial Sloan Kettering Cancer Center', 'Cancer survivor', 'CIPN'], 'conditions': ['Chemotherapy-induced Peripheral Neuropathy', 'Nerve Pain', 'Neuropathy', 'Neuropathy, Painful', 'Pain', 'CIPN - Chemotherapy-Induced Peripheral Neuropathy', 'Chronic Pain']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to test whether yoga can reduce nerve pain caused by cancer treatment (chemotherapy-induced peripheral neuropathy, or CIPN). Participants will take one of three approaches:\n\n* Yoga classes\n* Educational sessions on the causes and impacts of CIPN, how yoga may help with CIPN, and how different therapies may help with CIPN\n* Usual care with standard-of-care medications for CIPN\n\nThe researchers will compare how these different approaches affect participants' balance, their risk of falls, and their quality of life. This study will also measure how much yoga can help the reduced sense of touch caused by CIPN.\n\nThe functional assessments TUG and CTS can be safely completed either virtually and in-person and will be mandatory for all patients. The functional assessment FRT and QST assessments that can only be completed in-person are optional at these time points."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English-proficient men and women aged ≥18 years\n* Free of oncologic disease or or stable disease by clinical examination and history\n* Completed neurotoxic chemotherapy such as platinum agents, taxanes, vinca alkaloids, and bortezomib at least three months prior to enrollment\n* Diagnosis of CIPN based on symptom history, loss of deep tendon reflexes, or the presence of symmetrical stocking-glove pain, numbness, or paresthesia Grade ≥1 sensory pain based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0\n* Self-reported moderate to severe CIPN pain, as defined by a score of 4 or greater on the BPI-SF average pain item over the past week\n* On a stable regimen (no change in three months) if taking anti-neuropathy or other pain medications and not taking acetyl-L-carnitine 77\n* Willing to adhere to requirement that no new pain medication be taken throughout the first 12 weeks of the study period\n* Willing to adhere to all study-related procedures, including randomization to one of the three arms\n* Patient answers "Yes" to at least one factor in the question: "Do you think your balance, gait, posture, alignment, or flexibility has been affected by your experience of CIPN?"\n\nExclusion Criteria:\n\n* Patients who have received physical therapy or practiced yoga for CIPN in the past 3 months. As patients who have received physical therapy or practiced yoga in this time period may already be experiencing its benefits, we will exclude such patients.'}, 'identificationModule': {'nctId': 'NCT05121558', 'briefTitle': 'The Effect of Yoga on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'A Randomized Phase III Clinical Trial of Yoga for Chemotherapy-induced Peripheral Neuropathy Treatment (YCT)', 'orgStudyIdInfo': {'id': '23-517'}, 'secondaryIdInfos': [{'id': 'R01CA251470', 'link': 'https://reporter.nih.gov/quickSearch/R01CA251470', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yoga', 'description': 'Participants will receive twice weekly yoga over the course of 8 weeks.', 'interventionNames': ['Other: Yoga']}, {'type': 'EXPERIMENTAL', 'label': 'Education control (EC)', 'description': 'Participants will receive twice weekly education over the course of 8 weeks', 'interventionNames': ['Other: Education control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care (UC)', 'description': '8 weeks of usual care', 'interventionNames': ['Other: Usual care']}], 'interventions': [{'name': 'Yoga', 'type': 'OTHER', 'description': "Participants will have instructional yoga classes twice each week over the course of 8 weeks. Each yoga class will be 60 minutes, and it will be taught by an experienced yoga instructor. Participants will be provided with a home-based guided program for days classes are not held. Participants in the yoga group will also have the option to participate in a recorded final check-in session after they have completed their 16 yoga classes. The discussion facilitator will follow the Semi-Structured Interview Guide to further understand participants' experiences in the yoga group.", 'armGroupLabels': ['Yoga']}, {'name': 'Education control', 'type': 'OTHER', 'description': 'Participants will have educational sessions over 8 weeks. The sessions will be on the causes and impact of Chemotherapy-Induced Peripheral Neuropathy (CIPN), how yoga may help with CIPN, and how different therapies may help with CIPN. To encourage participation and adherence, patients in the EC group will receive sixteen free yoga sessions after completing the study. Patients in the EC group will be asked to not go for their own yoga classes locally until their participation in the study is completed.', 'armGroupLabels': ['Education control (EC)']}, {'name': 'Usual care', 'type': 'OTHER', 'description': 'Participants in the usual care control group will complete the same assessments as the other two arms. To encourage participation and adherence, patients in the UC group will receive sixteen free yoga sessions after completing the study. Patients in the UC group will be asked to not go for their own yoga classes locally until their participation in the study is completed.', 'armGroupLabels': ['Usual care (UC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ting Bao, MD', 'role': 'CONTACT', 'email': 'ting_bao@dfci.harvard.edu', 'phone': '857-215-2844'}, {'name': 'Ting Bao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jun Mao, MD, MSCE', 'role': 'CONTACT', 'phone': '646-888-0866'}], 'facility': 'Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jun Mao, MD, MSCE', 'role': 'CONTACT', 'phone': '646-888-0866'}], 'facility': 'Memorial Sloan Kettering Monmouth (Limited Protocol Activities)', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jun Mao, MD, MSCE', 'role': 'CONTACT', 'phone': '646-888-0866'}], 'facility': 'Memorial Sloan Kettering Bergen (Limited Protocol Activities)', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jun Mao, MD, MSCE', 'role': 'CONTACT', 'phone': '646-888-0866'}], 'facility': 'Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jun Mao, MD, MSCE', 'role': 'CONTACT', 'phone': '646-888-0866'}], 'facility': 'Memorial Sloan Kettering Westchester (Limited Protocol Activities)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jun Mao, MD,MSCE', 'role': 'CONTACT', 'phone': '646-888-0866'}, {'name': 'Wanqing Zhi, MD, PhD', 'role': 'CONTACT', 'phone': '631-623-4246'}], 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Rockville Centre', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jun Mao, MD, MSCE', 'role': 'CONTACT', 'phone': '646-888-0866'}], 'facility': 'Memorial Sloan Kettering Nassau (Limited Protocol Activities)', 'geoPoint': {'lat': 40.65871, 'lon': -73.64124}}], 'centralContacts': [{'name': 'Ting Bao, MD', 'role': 'CONTACT', 'email': 'ting_bao@dfci.harvard.edu', 'phone': '(857) 215-2844'}, {'name': 'Natalie Viyaran', 'role': 'CONTACT', 'email': 'natalie_viyaran@dfci.harvard.edu'}], 'overallOfficials': [{'name': 'Ting Bao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data can be shared no earlier than 1 year following the date of publication', 'ipdSharing': 'YES', 'description': 'The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ting Bao, MD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}